TCM Daoyin for Anxiety/Depression: Psychological Effects and Biological Mechanisms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-10

Study Completion Date

2027-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This 12-week single-arm clinical trial investigates the effects of Traditional Chinese Medicine (TCM) Daoyin exercise on anxiety and depression symptoms in 20 participants, followed by a 12-week observational follow-up period.

The primary outcome is the change in Hamilton Anxiety Rating Scale (HAMA-14) and Hamilton Depression Rating Scale (HAMD-17) scores at 12 weeks. A secondary outcome will assess these scores at 24 weeks to evaluate sustained effects. Additional secondary outcomes include the Depression, Anxiety, and Stress Scale (DASS-21) and Pittsburgh Sleep Quality Index (PSQI) to further assess changes in mood and sleep quality at the same time points.

Exploratory analyses will examine inflammatory markers, immune cell subsets, serum metabolomics, and gut microbiota at baseline, 12 weeks, and 24 weeks to identify potential biological correlates. During the follow-up period, participants will record their actual exercise engagement, allowing investigators to explore long-term associations. Findings may provide insights for future mechanistic studies on TCM's role in mental health.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

TCM Daoyin in the Treatment of Patients With Anxiety State

NCT05932095

Anxiety State

COMPLETED NA

Baduanjin Training for Depression and Anxiety Patients

NCT05589337

Depression Symptoms Anxiety Symptoms

RECRUITING NA

Establishing TCM Daycare Model and Teaching Mechanism of Depression Patients

NCT04469608

Traditional Chinese Medicine Major Depressive Disorder

UNKNOWN NA

Ba Duan Jin for Depression and Anxiety

NCT04673370

Depression, Anxiety

COMPLETED NA

Comparison of Treatment Effect of Chinese Medicine and Western Medicine on Depression in China and America

NCT01558154

Depression

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Anxiety and depression are among the most prevalent mental health conditions and are commonly associated with inflammation, immune dysregulation, and metabolic disturbances. Traditional Chinese Medicine (TCM) interventions, such as Daoyin exercise-a form of guided movement and breathing-have historically been used to promote mental well-being. However, their biological mechanisms remain inadequately understood.

This 12-week, single-arm clinical trial aims to evaluate the effects of a structured Daoyin exercise program on subclinical anxiety and depression symptoms in 20 adult participants. After completing the 12-week intervention, participants will enter a 12-week observational follow-up period, during which they may choose to continue or discontinue the practice at their discretion. Actual exercise engagement during the follow-up will be self-recorded using daily logs.

The primary outcome is the change in Hamilton Anxiety Rating Scale (HAMA-14) and Hamilton Depression Rating Scale (HAMD-17) scores from baseline to 12 weeks. A secondary outcome will assess the persistence of these effects at 24 weeks. Additional psychological assessments include the Depression, Anxiety, and Stress Scale (DASS-21) and the Pittsburgh Sleep Quality Index (PSQI), evaluated at baseline, 12 weeks, and 24 weeks to assess broader changes in mood and sleep quality.

Exploratory outcomes will investigate potential biological mechanisms by measuring:

* Inflammatory markers (e.g., interleukin-10 \[IL-10\], interleukin-6 \[IL-6\], tumor necrosis factor-alpha \[TNF-α\]) via serum ELISA
* Immune cell subsets (e.g., cluster of differentiation 3-positive \[CD3+\], cluster of differentiation 4-positive \[CD4+\], cluster of differentiation 8-positive \[CD8+\] T cells) via flow cytometry
* Serum metabolomics using liquid chromatography-mass spectrometry (LC-MS) to identify metabolic changes potentially related to the effects of Daoyin exercise on anxiety and depression
* Gut microbiota composition using high-throughput sequencing techniques

Samples will be collected at baseline, 12 weeks, and 24 weeks. These data will help identify physiological pathways potentially linked to improvements in anxiety and depression symptoms.

Participants will be included based on clinician assessment and confirmed subclinical symptoms, with HAMA-14 scores between 14-29 and HAMD-17 scores between 7-14, without meeting ICD-10 diagnostic criteria for anxiety or depressive disorders. All psychological and biological evaluations will occur at three time points: baseline, post-intervention (12 weeks), and follow-up (24 weeks).

The results may offer preliminary evidence for integrating Daoyin exercise into mental health self-management strategies and provide a foundation for future research into TCM's biological mechanisms.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Symptom Depression Symptom

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a single-arm trial with 20 participants undergoing a 12-week TCM Daoyin exercise intervention (2 sessions per week), followed by a 12-week observational follow-up period. Primary outcomes (HAMA-14 and HAMD-17 scores) and exploratory biomarkers (inflammatory markers, immune cell subsets, and serum metabolomics) will be assessed at baseline, 12 weeks, and 24 weeks. No control group is included.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open-label, single-arm trial. While no formal masking is applied, the outcomes assessor will not have access to participant adherence records or follow-up exercise engagement data to minimize assessment bias.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TCM Daoyin Exercise Group

Participants will receive a 12-week TCM Daoyin training program led by qualified physicians. Structured group sessions will incorporate movement regulation, breath regulation, and mind regulation to alleviate anxiety and depression symptoms.

Group Type EXPERIMENTAL

TCM Daoyin exercise

Intervention Type BEHAVIORAL

Participants will receive a 12-week, group-based TCM Daoyin intervention consisting of two 90-minute sessions per week (total: 24 sessions), led by qualified physicians. Each session integrates movement regulation, breath regulation, and mind regulation, aiming to alleviate anxiety and depression symptoms. Each session includes a 10-minute warm-up and a 10-minute cool-down.

Compliance and Analysis:

Per-protocol analysis will include participants who attend ≥80% of sessions (≥19/24 sessions). Safety analyses will be conducted on all enrolled participants (n=20) following the intention-to-treat (ITT) principle.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TCM Daoyin exercise

Participants will receive a 12-week, group-based TCM Daoyin intervention consisting of two 90-minute sessions per week (total: 24 sessions), led by qualified physicians. Each session integrates movement regulation, breath regulation, and mind regulation, aiming to alleviate anxiety and depression symptoms. Each session includes a 10-minute warm-up and a 10-minute cool-down.

Compliance and Analysis:

Per-protocol analysis will include participants who attend ≥80% of sessions (≥19/24 sessions). Safety analyses will be conducted on all enrolled participants (n=20) following the intention-to-treat (ITT) principle.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Primary symptoms of anxiety and depression, with a Hamilton Anxiety Rating Scale (HAMA-14) score between 14 and 29 and a Hamilton Depression Rating Scale (HAMD-17) score between 7 and 14.
* No prior use of psychotropic medication, or at least six months since discontinuation.
* Aged 18 to 65 years (male or female).
* Clear consciousness and normal cognitive function, with the ability to communicate effectively, read, express thoughts, and engage in daily activities independently.
* Willing and able to comply with blood and stool sample collection.
* Voluntary participation, with signed informed consent provided before enrollment.

Exclusion Criteria

* Diagnosed anxiety disorder or depressive disorder based on ICD-10 criteria.
* Bipolar disorder, psychotic disorders (e.g., schizophrenia), or organic mental disorders (e.g., Alzheimer's disease).
* History of alcohol or substance use disorder within the past year, current psychiatric medication use, or high suicide risk.
* Severe or unstable medical conditions, including immune or endocrine disorders or other serious illnesses.
* Physical or psychological limitations preventing participation in the TCM Daoyin intervention.
* Pregnant or breastfeeding women.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No